Drug Treatment for Alcoholics With Post-Traumatic Stress Disorder - Tabular View

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00000446 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Drug Treatment for Alcoholics With Post-Traumatic Stress Disorder
Official Title ^ICMJE	Sertraline Treatment in Comorbid Post-Traumatic Stress Disorder and Alcoholism
Brief Summary	This study will investigate the use of sertraline (Zoloft) to decrease alcohol consumption and crime-related post-traumatic stress disorder in those individuals with both disorders. This will be a 12-week, placebo-controlled, double-blind outpatient trial. All subjects will receive cognitive behavioral therapy in addition to a placebo or sertraline. Comprehensive evaluation will be done at study entry; treatment termination; and 6, 9, and 12 months after study entry.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study
Condition ^ICMJE	Alcoholism Post-Traumatic Stress Disorder
Intervention ^ICMJE	Drug: sertraline (Zoloft)
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date	December 2000
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: Meets criteria for alcohol abuse or dependence and post-traumatic stress disorder. Laboratory tests for blood and urinalysis must be within normal limits. Must be clearly motivated to obtain benefit from treatment and keep appointments for study visits and therapy sessions. Females who use an acceptable method of birth control, are sterilized, or are at least 2 years post-menopausal. Exclusion Criteria: Have a diagnosis of schizophrenia, bipolar affective disorder, dissociative identity disorder, eating disorder, substance dependence in the last 60 days. Currently suicidal. Medical reasons not to receive drug therapy. Allergy or hypersensitivity to selective serotonin inhibitor antidepressants. Significant hematological, endocrine, cardiovascular, renal, hepatic, neurological, or gastrointestinal disease. Liver function test greater than 2 times the normal level Require ongoing therapy with another psychoactive drug during the study period. Females who are pregnant or lactating.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00000446
Responsible Party
Study ID Numbers ^ICMJE	NIAAABRA10761
Study Sponsor ^ICMJE	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Verification Date	April 2004
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP